41 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 3, 2013
PORTEX ANESTHESIA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD·Product code CAI·September 8, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 5, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·September 14, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 3, 2015
VUELOCK PLATE, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2015
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 2020
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 8, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 17, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 25, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·November 6, 2014
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·September 9, 2015